NCT04180501Unknown2 期
A Phase II Study on the Treatment of Advanced Non-small Cell Lung Cancer With Brain Metastasis by SRS Sequential Sintilimab
Xiaorong Dong1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- iPFSof NSCLC patients receiving SRS sequential sintilimab
研究概览
简要总结
A phase II study on the treatment of advanced non-small cell lung cancer with brain metastasis by SRS sequential sintilimab
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-small cell lung cancer patients with less than brain metastases
- •Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment
- •Patients who have not received intracranial local treatment before
排除标准
- •Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds
- •Patients with hemorrhage in intracranial metastasis
结局指标
主要结局
iPFSof NSCLC patients receiving SRS sequential sintilimab
时间窗: 1 year
From the beginning of treatment to the end of follow-up study, when the longest diameter of brain metastases treated by SRS was more than 30% smaller than the baseline level at any time of efficacy evaluation, the objective remission of the lesions was achieved. The time from the objective remission to the next progress of the intracranial lesions was recorded as the intracranial progression-free survival(iPFS).
次要结局
未报告次要终点
研究者
Xiaorong Dong
Professor
Wuhan Union Hospital, China
研究点 (1)
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